Device Classification Name |
material, impression
|
510(k) Number |
K896786 |
Device Name |
ZONAREX FINAL IMPRESSION COMPOUND |
Applicant |
CRAFT DENTAL LABORATORY, INC. |
1583 WEST FOREST HOME AVE. |
MILWAUKEE,
WI
53204
|
|
Applicant Contact |
DALE B PARASK |
Correspondent |
CRAFT DENTAL LABORATORY, INC. |
1583 WEST FOREST HOME AVE. |
MILWAUKEE,
WI
53204
|
|
Correspondent Contact |
DALE B PARASK |
Regulation Number | 872.3660
|
Classification Product Code |
|
Date Received | 12/04/1989 |
Decision Date | 04/19/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|